NEW YORK--(BUSINESS WIRE)--Regulatory News:
“Note Regarding Use of Non-GAAP Financial Measures”
Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced its results for the three-month period ended March 31, 2017.
RECENT CORPORATE HIGHLIGHTS
Cellectis - Therapeutics
UCART123 - Cellectis’ most advanced, wholly controlled TALEN® gene-edited product candidate
- Investigational New Drug (IND) approval received from the U.S. Food and Drug Administration (FDA) to conduct Phase I clinical trials in patients with AML and BPDCN.
- First clinical trial approval by the FDA for an allogeneic, “off-the-shelf” gene-edited CAR T-cell product candidate.
- AML clinical program to be led, at Weill Cornell, by Gail J. Roboz, MD, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine.
- BPDCN clinical program to be led, at MD Anderson Cancer Center, by Naveen Pemmaraju, MD, Assistant Professor, and Hagop Kantarjian, MD, Professor and Department Chair, Department of Leukemia, Division of Cancer Medicine.
- Completion of cGMP manufacturing runs of UCART123 at large scale, to provide doses for initiating planned Phase I clinical trials in AML and BPDCN patients.
UCART19, exclusively licensed to Servier
- The FDA has granted Pfizer and Servier with Investigational New Drug (IND) clearance to proceed in the U.S. with Phase I clinical development of UCART19 to treat patients with relapsed/refractory acute lymphoblastic leukemia.
- Phase I clinical trials in pediatric and adult ALL patients are ongoing at University College London (UCL) and Kings College London (KCL), UK, sponsored by Servier.
Scientific Conferences
-
Data on both wholly-controlled Cellectis programs and Pfizer/Cellectis
collaboration programs have been presented at the American Association
for Cancer Research (AACR) Annual Meeting:
- UCART22: An allogeneic adoptive immunotherapy for leukemia targeting CD22 with CAR T-cells
- Allogeneic EGFRvIII Chimeric Antigen Receptor T-cells for treatment of glioblastoma
- Differential modulation of the PD-1 pathway impacts the anti-tumor activity of CAR T-cells
Clinical Advisory Board
- Formation of a Clinical Advisory Board (CAB) comprising leading experts in the hematologic malignancies / stem cell transplant, immunotherapy and hematology-oncology clinical research fields to serve as a strategic resource to Cellectis in connection with the clinical development of UCART123.
Calyxt Inc. – Cellectis’ plant science subsidiary
- In April 2017, Cellectis announced that it is exploring the possibility of an initial public offering (IPO) of a minority interest in its plant sciences business, Calyxt.
- New Technology Framework Agreement with Plant Bioscience Limited pursuant to which Calyxt received an option to obtain exclusive license to new crops traits.
- Former Cargill executive Manoj Sahoo joined Calyxt as the Company’s Chief Commercial Officer. As part of Calyxt’s executive team Mr. Sahoo is building a commercial partnership network and executing a go-to-market plan for Calyxt. Mr. Sahoo is joining Calyxt from Cargill, where he worked in the Food Ingredients and Bio-industrial Enterprise
Financial Results
Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“IASB”).
